NCT03038828

Study of Leukocyte Interleukin, Injection for Treatment of Perianal Warts

Phase 1 Dose Escalation Study to Establish the Safety of Leukocyte Interleukin, Injection for Treatment of Perianal Warts in Adult Men and Women Who Are HIV/HPV Co-infected

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: CEL-SCI Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Study is a dose escalation study. Fifteen patients will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten participants will be treated in cohort B. Cohort B participants will be treated the same as cohort A participants except that dose will be increased to 400IU Multikine per day.

Detailed description

Study is a dose escalation study to determine the safety of Leukocyte Interleukin, Injection in treating men and women with perianal warts who are HIV/HPV co-infected. Fifteen patients will be enrolled in 2 treatment cohorts. Five participants (cohort A) will be treated with 200IU Multikine daily, 5 days/week for 2 weeks, off 2 weeks, then treated again 5 days/week for 2 weeks. If no serious adverse events are noted in cohort A patients, ten (10) participants will be treated in cohort B. Cohort B participants will be treated in the same manner as cohort A participants except that the dose will be increased to 400IU Multikine per day.

Conditions

• Perianal Warts

Interventions

Type	Name	Description
BIOLOGICAL	Leukocyte Interleukin, Injection	Immunotherapy

Timeline

• Start date: 2015-04-01
• Primary completion: 2018-06-01
• Completion: 2018-09-01
• First posted: 2017-02-01
• Last updated: 2023-09-22

Locations

2 sites across 1 country: United States